RADIANT: A Study of Radium-223 Dichloride (Xofigo) vs Enzalutamide or Abiraterone (ARPIs, Androgen Receptor Pathway Inhibitors) in Patients With Prostate Cancer That Has Spread to the Bones (mCRPC, Metastatic Castration-Resistant Prostate Cancer)
This study, called RADIANT, looks at two ways to treat prostate cancer that has spread to the bones and is no longer responding to standard hormone therapy. Researchers want to compare a radioactive drug, Radium-223 (also known as Xofigo), with another type of hormone therapy called ARPIs (like enzalutamide or abiraterone). The main goals are to see which treatment works better to slow down the cancer and relieve symptoms, and also to understand their safety profiles. Participants will receive one of these treatments and be monitored regularly. This research helps doctors find the best ways to help men with this type of advanced prostate cancer feel better and live longer.
At a glance
What is this study about?
This study is for men with prostate cancer that has spread to their bones and has become resistant to standard hormone treatments. This type of cancer is often called metastatic castration-resistant prostate cancer (mCRPC). The study aims to compare two different treatments that are already approved for this condition: Radium-223 dichloride (known as Xofigo) and a group of hormone treatments called ARPIs (Androgen Receptor Pathway Inhibitors), which include drugs like enzalutamide or abiraterone.
Radium-223 works in a special way. Once injected into your body, it goes straight to the bones where the cancer has spread. It then releases a type of radiation that travels a very short distance, specifically targeting and killing the cancer cells in the bones, while trying to cause less harm to healthy cells nearby. ARPIs, on the other hand, are powerful hormone treatments that block the signals that help prostate cancer cells grow. Both types of treatment are used to manage prostate cancer that has spread to the bones, and this study wants to see how they stack up against each other in terms of how well they work and their side effects.
The main goal is to find out if one treatment is better at controlling the cancer and improving quality of life for patients who have already tried one type of ARPI therapy. This research is important because it helps doctors understand the best next steps for treatment, giving patients more options and potentially better outcomes in the future.
Key takeaways
- Compares two approved treatments for advanced prostate cancer in bones.
- Investigates Radium-223 (Xofigo) versus ARPI hormone therapy.
- For men whose cancer has progressed after one ARPI treatment.
- Aims to assess both effectiveness and safety.
- Involves regular hospital visits and monitoring over two years.
- You will be closely monitored for your health and any side effects.
Who may be eligible?
To join this study, you would generally need to be a man whose prostate cancer has been confirmed by a doctor and has spread to your bones. Importantly, your cancer should have already been treated with one type of ARPI drug (like abiraterone or enzalutamide) for at least three months, and it has since started to get worse. You might also have had previous chemotherapy for your cancer, or your doctor might have decided against it for medical reasons.
Your cancer should only be in the bones, meaning it hasn't spread to other organs like your lungs, liver, or brain. You should also be experiencing some pain due to your cancer. Your general health should be good enough to participate, as determined by a doctor's assessment, and you should be able to swallow tablets or capsules whole. There are also specific blood test results that you would need to meet.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you a man with prostate cancer that has spread to your bones?
- Has your cancer already been treated with an ARPI drug (like abiraterone or enzalutamide) for at least 3 months, and has it started to get worse?
- Does your cancer only affect your bones, without spreading to other organs like lungs or liver?
- Are you experiencing some pain from your prostate cancer?
- Are you generally well enough to participate, as assessed by a doctor?
What does participation involve?
If you join this study, you will either receive Radium-223 dichloride or an ARPI drug. If you get Radium-223, it will be given as a drip into your vein once every four weeks, for up to six treatments in total. If you get an ARPI drug, you will take it as a tablet once daily, and you'll continue taking it until your cancer gets worse.
For the first six treatment cycles, you will visit the hospital or clinic every two weeks. After that, from the seventh cycle onwards, you will only need to visit on the first day of each cycle. The researchers will follow your progress for about two years in total. During your visits, blood and urine samples will be collected to monitor your health and the effects of the treatment. You will also be asked to fill out questionnaires about how you are feeling and any pain you might be experiencing, which helps the researchers understand the impact of the treatments on your day-to-day life.
Potential risks and benefits
Locations (118)
- Specialist Services Medical GroupVerified postcodeCastle Hill, Australia
- Gosford HospitalVerified postcodeGosford, Australia
- Nepean HospitalVerified postcodeKingswood, Australia
- North West Cancer CentreVerified postcodeNorth Tamworth, Australia
- Northern Cancer InstituteVerified postcodeSt Leonards, Australia
- Prince of Wales Hospital NSWVerified postcodeSydney, Australia
- Illawarra Shoalhaven Local Health DistrictVerified postcodeWollongong, Australia
- Icon Cancer CareVerified postcodeBrisbane, Australia
- Tasman Health CareVerified postcodeSouthport, Australia
- The Tweed HospitalVerified postcodeTugun, Australia
- Royal Adelaide HospitalVerified postcodeAdelaide, Australia
- Klinik Ottakring - WilhelminenspitalUnverifiedVienna, Austria
Common questions
What is mCRPC?
mCRPC stands for metastatic castration-resistant prostate cancer. This means your prostate cancer has spread to other parts of your body (metastatic), usually bones, and is no longer being controlled by standard hormone therapy (castration-resistant).
What is Radium-223?
Radium-223 (Xofigo) is a radioactive medicine that specifically targets cancer cells in your bones, helping to kill them and slow down the spread of the cancer.
What are ARPIs?
ARPIs, like enzalutamide (Xtandi) or abiraterone (Zytiga), are hormone therapies that block signals that help prostate cancer cells grow. They are standard treatments for advanced prostate cancer.
Will I know which treatment I'm receiving?
The study design will determine if you know which treatment you are receiving. The study team will explain this to you before you agree to participate.
How long will I be in the study?
You will be followed by the study team for about two years in total, with regular visits and monitoring.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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